Usp42-Nf37 2593

Printed on: Tue Dec 22 2020, 02:28:54 AM Official Status: Currently Official on 22-Dec-2020 DocId: 1_GUID-AA7C755C-5EF7-418D-97A8-20E6A2A151FA_3_en-US
(EST)
Printed by: Jinjiang Yang Official Date: Official as of 01-Jan-2018 Document Type: NF @2020 USPC
1
Standard curve
Potassium Hydroxide Samples: Standard solutions
KOH 56.11 Plot: Absorbance values versus their corresponding
Potassium hydroxide [1310-58-3]. concentrations (µg/mL) of potassium. The correlation
coefficient is NLT 0.999.
DEFINITION Analysis
Potassium Hydroxide contains NLT 85.0% of total alkali, Sample: Sample solution
calculated as potassium hydroxide (KOH), including NMT From the Standard curve, determine the concentration of
3.5% of potassium carbonate (K2CO3). It also contains NLT potassium in the Sample solution.
59.9% of potassium. Calculate the percentage of potassium in the portion of
[CAUTION—Exercise great care in handling Potassium Potassium Hydroxide taken:
Hydroxide because it rapidly destroys tissues.]
Result = (C S/C U) × 100
IDENTIFICATION
• A. IDENTIFICATION TESTS—GENERAL á191ñ, Potassium: A CS = concentration of potassium in the Sample solution
solution (1 in 25) meets the requirements. from the Standard curve (µg/mL)
• B. PH á791ñ CU = concentration of Potassium Hydroxide in the
Sample solution: 0.1 mg/mL of Potassium Hydroxide Sample solution (µg/mL)
Acceptance criteria: NLT 10.5
Acceptance criteria: NLT 59.9%
ASSAY
• TOTAL ALKALI IMPURITIES
Sample: 1.5 g of Potassium Hydroxide • LIMIT OF SODIUM
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Titrimetric system Diluent: 1% hydrochloric acid solution
(See Titrimetry á541ñ.) Standard stock solution: 12.71 µg/mL of sodium chloride,
Mode: Direct titration previously dried at 105° for 2 h, in water. This solution
Titrant: 1 N sulfuric acid VS contains 5 µg/mL of sodium.
Endpoint detection: Colorimetric ci Standard solutions: Transfer 1.0-, 10.0-, and 15.0-mL
Analysis: Dissolve the Sample in 40 mL of carbon dioxide– portions of the Standard stock solution to separate 100-mL
free water. Cool the solution to 15° and add volumetric flasks. Dilute the content of each flask with
phenolphthalein TS. Titrate with 1 N sulfuric acid VS. At the Diluent to volume and mix to obtain solutions with known
discharge of the pink color of the indicator, record the concentrations of 0.05, 0.5, and 0.75 µg/mL of sodium.
volume of acid solution required, then add methyl Sample stock solution: 0.5 mg/mL of Potassium Hydroxide
orange TS and continue the titration to a persistent pink Sample solution: 50 µg/mL of Potassium Hydroxide in
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color. Each milliliter of 1 N sulfuric acid is equivalent to Diluent, prepared from the Sample stock solution
56.11 mg of total alkali, calculated as potassium hydroxide Instrumental conditions
(KOH), and each milliliter of acid consumed in the titration (See Atomic Absorption Spectroscopy á852ñ.)
with methyl orange is equivalent to 138.2 mg of potassium Mode: Atomic absorption spectrophotometry
carbonate (K2CO3). Analytical wavelength: 589.0 nm
Acceptance criteria: NLT 85.0% of total alkali, calculated as Lamp: Sodium hollow-cathode
O
potassium hydroxide (KOH), including NMT 3.5% of Flame: Air–acetylene

potassium carbonate (K2CO3) Blank: Diluent
• CONTENT OF POTASSIUM Standard curve
Diluent: 1% hydrochloric acid solution Samples: Standard solutions
Sodium chloride solution: 0.2 g/mL of sodium chloride Plot: Absorbance values versus their corresponding
Blank solution: Transfer 2.0 mL of the Sodium chloride concentrations (µg/mL) of sodium. The correlation
solution to a 100-mL volumetric flask and dilute with Diluent coefficient is NLT 0.995.
to volume. Analysis
Standard stock solution: 57.21 µg/mL of potassium Sample: Sample solution
chloride, previously dried at 105° for 2 h, in water. This From the Standard curve, determine the concentration of
solution contains 30 µg/mL of potassium. sodium in the Sample solution.
Standard solutions: Transfer 2.0-, 4.0-, and 6.0-mL Calculate the percentage of sodium in the portion of
portions of the Standard stock solution to separate 100-mL Potassium Hydroxide taken:
volumetric flasks. To each flask, add 2.0 mL of the Sodium
chloride solution. Dilute the content of each flask with Result = (C S/C U) × 100
Diluent to volume and mix to obtain solutions with known
concentrations of 0.6, 1.2, and 1.8 µg/mL of potassium. CS = concentration of sodium in the Sample solution
Sample stock solution: 0.5 mg/mL of Potassium Hydroxide from the Standard curve (µg/mL)
Sample solution: Transfer 1.0 mL of the Sample stock CU = concentration of Potassium Hydroxide in the
solution to a 250-mL volumetric flask. Add 5.0 mL of the Sample solution (µg/mL)
Sodium chloride solution and dilute with Diluent to volume.
Instrumental conditions Acceptance criteria: NMT 1.0%
(See Atomic Absorption Spectroscopy á852ñ.) SPECIFIC TESTS
Mode: Atomic absorption spectrophotometry • INSOLUBLE SUBSTANCES
Analytical wavelength: 766.5 nm (potassium emission Sample solution: 1 g of Potassium Hydroxide in 20 mL of
line) water
Lamp: Potassium hollow-cathode Acceptance criteria: The Sample solution is complete, clear,
Flame: Air–acetylene and colorless.
Blank: Blank solution
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(EST)
Printed by: Jinjiang Yang Official Date: Official as of 01-Jan-2018 Document Type: NF @2020 USPC
2
ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in tight containers.
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Printed on: Tue Dec 22 2020, 02:28:54 AM Official Status: Currently Official on 22-Dec-2020 DocId: 1_GUID-AA7C755C-5EF7-418D-97A8-20E6A2A151FA_3_en-US

potassium hydroxide (KOH), including NMT 3.5% of Flame: Air–acetylene

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